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This is a prospective, interventional, double-blinded placebo-controlled study of up to 40 participants to evaluate the effect of a botanical formulation on inflammatory and cardiovascular biomarkers .
The objective of this study is to understand the impact of a multi-botanical formulation on measurements of protein markers, with a focus on inflammation over a 60-day period. The primary objective of this study is to assess the effect of the formulation, LLP-01, on inflammatory and cardiovascular proteomic biomarkers. Adverse events will be self-monitored by participants and will be reported. Changes in weight/calculated BMI and grip strength, as well as changes in well-being through a self-reported questionnaire will also be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Participants in this arm will receive a herbal capsule formulation, called LLP-01, consisting of 2 capsules taken once daily without food for 60 days. The capsules contain extracts from naturally occurring plant species, including Withania somnifera, Rosmarinus officinalis, Curcuma longa, Cotinus coggygria, Panax ginseng, Cordyceps militaris, Camellia sinensis, Cotinus coggygria, and Piper nigrum. |
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| Placebo Group | Placebo Comparator | Participants in this arm will receive Placebo capsules, which are visually identical to the capsules in the Experimental Group. These placebo capsules are filled with rice flour and a minor amount of Curcuma longa powder and should be taken in the same manner as the Experimental Group, with 2 capsules taken once daily without food for 60 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LLP-01 | Dietary Supplement | Participants in the experimental group will take 2 capsules daily containing 1,000mg of the formulation, LLP-01, for 60 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma Proteomic Changes | Serum proteomic test to measure significant effects on any of the plasma proteins that will be analyzed. These proteins represent inflammatory, and cardiovascular responses, as well as metabolic functions. | Change from baseline to 60 days and compared to placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Grip Strength | Digital grip strength device to measure absolute grip strength | Change from baseline to 60 days and compared to placebo |
| Weight/BMI | Height and weight to measuring absolute weight and to calculate BMI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adi Ramon, M.Sc | Chief Compliance Officer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LL Prosper Inc. | San Diego | California | 92121 | United States |
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2 month, double blind placebo controlled study.
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| Placebo | Other | Participants in the placebo group will take 2 capsules daily containing rice flower and small amount of Curcuma Longa for 60 days. |
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| Change from baseline to 60 days and compared to placebo |
| Well-being | Questionnaire covering different aspects of well-being | Change from baseline to 60 days and compared to placebo |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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